Tag Archives: Final Rule

FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, 2017 by the Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO). The Petition argued that the Final Rule’s inclusion of a “totality of the evidence” standard is a new standard not found in the Food, Drug, and Cosmetic Act (FDCA) or case law related to intended use and was promulgated in violation in the APA because parties subject to this significant liability standard did not receive fair notice or a meaningful opportunity to comment.

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Filed under FDA, FDA Final Guidance

OIG Issues Final Rule Re: Exclusion Authority

The Final Rule related to the Health and Human Services Office of Inspector General’s (OIG) exclusion authority pursuant to the Social Security Act (the Act), as amended by the Affordable Care Act (ACA) and the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA), was released last week. The Proposed Rule was issued previously by the OIG in May 2014. The effective date of the Final Rule is February 13, 2017.

Noteworthy changes made by the Final Rule include the following key items:

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Filed under Fraud and Abuse, Government Enforcement, OIG Guidance

Final Medicare 60-Day Overpayment Rule Provides Reasonable Framework for Providers

Published today in the Federal Register was a long-awaited Final Rule implementing a requirement from the 2010 Affordable Care Act requiring Medicare Part A and B providers and suppliers to report and return overpayments to Medicare by the later of 60 days after the date an overpayment was identified, or the due date of any corresponding cost report, if applicable (Overpayment Rule). The Proposed Rule was previously published on February 16, 2012. Additionally, the final rule implementing overpayments in Medicare Parts C and D was previously published in May 2014. Case law interpreting the Overpayment Rule has been limited to date.

The Final Rule includes several significant clarifications, including the following:

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Filed under Fraud and Abuse, Health Reform, Medicare

CMS Exempts CME and Makes Other Sunshine Reporting Changes

Late last week, the Centers for Medicare and Medicaid Services (CMS) issued the 2015 physician payment fee schedule, which includes changes to the Final Rule implementing the federal Sunshine law.  Most significantly, CMS announced that it had exempted payments to speakers at all continuing medical education (CME) events under §403.904(i)(1) if the applicable manufacturer “provides funding to a continuing education provider, but does not either select or pay the covered recipient speaker directly, or provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program.”  According to CMS, this change “will create a more consistent reporting requirement, and will also be more consistent for consumers who will ultimately have access to the reported data.”  However, grants influenced by a company, and speakers paid directly by an applicable manufacturer, will continue to be subject to reporting.

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Filed under Federal Transparency

A Few Good Nuggets Related to Sunshine at Industry Conference

Today at the Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (PCF), the audience heard from Anita Griner, Deputy Director at the Centers for Medicare & Medicaid Services (CMS) who has responsibility related to Open Payments.  In addition to providing an overview of Sunshine implementation, Ms. Griner provided a few key updates to attendees: Continue reading

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Filed under Federal Transparency

Final Rule Released on ACA’s Individual Shared Responsibility Payment

On August 27, 2013, the Internal Revenue Service (“IRS”) and the U.S. Department of Treasury (the “Treasury Department”) released a final rule, Shared Responsibility Payment for Not Maintaining Minimum Essential Coverage, (the “Final Rule”), which was published in the Federal Register today, to implement the individual shared responsibility provision provided for under the Affordable Care Act (“ACA”). Starting in 2014, the individual shared responsibility provision requires each individual to have basic health insurance coverage (known as minimum essential coverage), qualify for an exemption, or make a shared responsibility payment (penalty) when filing a federal income tax return.  Continue reading

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Filed under Health Reform

TIME IS UP! Sunshine Data Tracking Starts Today

alarm clock

The day long awaited by the health care industry has finally arrived.  Today is the day that pharmaceutical, biotechnology and medical device manufacturers and group purchasing organizations (GPOs) must begin tracking payments and other transfers of value provided to “covered recipients” in accordance with Section 6002 of the Affordable Care Act (commonly known as the Sunshine Law) and the Final Rule issued by the Centers for Medicare & Medicaid Services (CMS) in February 2013.  The tracked data must be reported to CMS by March 31, 2014. 

Now that tracking has started, manufacturers and GPOs may be asking, “what’s next?”.  Efforts during this critical time period between today and March 31, 2014 should be maximized.  Here are a few things to consider if you are sitting around today thinking that your work is done:

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Filed under Federal Transparency